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510(k) Data Aggregation

    K Number
    K180720
    Device Name
    Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
    Manufacturer
    Date Cleared
    2018-06-27

    (100 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medibio Usa LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.
    Device Description
    The Medifine Pen Needle consists of a needle with hub, and shield assembly. The needle shield is intended to provide physical protection to the needle with the hub. Blister paper covers the primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.
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